Regulatory advocates urge FDA to advance global health tools

Kaitlin Christenson, manager of the Global Health Technologies Coalition, addresses a panel from the US Food and Drug Administration. Photo: PATH/Rachel Wilson.

On September 23, the Global Health Technologies Coalition and representatives from other leading global health organizations testified at a pivotal public hearing hosted by the US Food and Drug Administration (FDA). The hearing examined the FDA’s role in regulating and reviewing crucial global health technologies, such as vaccines, drugs, microbicides, diagnostics, and other tools that save lives worldwide.

Speakers offered the FDA several recommendations for expanding its effort to advance global health products, including the following:

Strengthen the FDA’s engagement with groups and entities, such as product-development partnerships, to develop tools to prevent, diagnose, and treat diseases of the developing world. Several speakers noted that it is crucial for the FDA to engage with nontraditional product sponsors, including product-development partnerships, at several stages of product development.

Help build regulatory capacity in developing nations through increased collaboration with countries and regional regulatory networks. Many countries in the developing world do not have the capacity or resources to regulate health tools and ensure that only safe and effective products are distributed to people in need.

Bolster the FDA’s partnership with global regulatory stakeholders, such as the World Health Organization (WHO). Stronger association between the FDA and partners such as WHO can help streamline the review of new global health tools and reduce the time it takes for lifesaving medical products to reach people in need.

Use incentive mechanisms, particularly the FDA’s Priority Review Voucher program, to help spur the development of new tools for diseases of the developing world.

The hearing was “extremely helpful” to the FDA’s neglected disease review group, said Leonard Sacks, acting director of the agency's Office of Critical Path Programs. He added that the hearing was only the “beginning of a process” and that there is “a lot of work ahead” for the FDA and its partners to help ensure the safety of health tools to prevent, diagnose, and treat infectious diseases that affect millions of people worldwide every year.

The hearing was hosted by the FDA’s newly mandated review group for neglected diseases of the developing world in preparation for a report the group will deliver to Congress next year on the topic.

About the GHTC

Housed at PATH and funded by the Bill & Melinda Gates Foundation, the Global Health Technologies Coalition includes more than 30 organizations advocating for research and development of tools to prevent, diagnose, and treat global diseases so health solutions are available when populations need them. For more information about the coalition, please see the GHTC website.